Oracle Argus Safety 8.1.1 – Whats new!

Oracle Argus Safety – 8.1.1 – New Features

Oracle Argus Safety 8.1.1 was officially few months back, so we thought we would share a question that came up recently from one of our prospective students who wanted to pursue a program in Pharmacovigilance and learn the Oracle Argus Safety software. The student asked us what the difference between Argus Safety 8.1 and 8.1.1 is. While there are your standard bug fixes and improvements, there are two significant changes that you should understand.

E2B(R3)

All companies that currently report safety data to regulatory agencies or partners using E2B will be required to adopt the new E2B(R3) format beginning in 2019. If you will be receiving cases from the European Medicines Agency (EMA) via the new EudraVigilance website, you will only be able to download these reports in R3 format. If you don’t upgrade to 8.1.1, you will need to use a backwards and forwards conversion (BFC) tool, which can transform the R3 file into an R2 file that you will then be able to import into Argus.

WHODrug B3/C3

The Uppsala Monitoring Centre (UMC) will be releasing WHODrug B3/C3, the new version of the dictionary, which will increase the length of two fields: CMCLAS and CMDECOD. This will help future-proof the dictionary. According to the UMC, the new version will be available alongside the current B2/C2 version until September 2018, at which point the new version will be the only option. While you will be able to load the new dictionaries into 8.1.1, Oracle said it will not be creating a patch for older versions.

Clinskill – Digital Learning Academy for Clinical Research now provides its students and professional 24×7 access to the latest version of Oracle Argus Safety version 8.1.1 as part of its programs, so that your learning is comprehensive and current as per regulatory requirements.